Focus on your Business.Not on Regulatory Compliance.
Our Partnering process starts with a talk to check if you and your needs match Decomplix’ offer.
First of all we need to know your needs and points of your product’s development. Do you have a medical device, standalone software or wearable? Does it need a CE mark for entering the market? What is the intended use and the indication for use of your product? To which risk class would it belong to? How can we proceed the best? We are happy to have a first talk for a quick assessment.
You get answers
- Is it a medical device?
- Do I need a CE mark?
- Which risk class?
- How can I proceed?
The evaluation shows you where you are in the development process and what’s next for a fast certification.
Our evaluation report serves you the decision basis for taking the next steps, independently of a partnership with Decomplix. You assess yourself with our checklist. Then, we analyze your product's top level documentation. On a confidential basis we identify gaps and differences up to your compliant product. This comprehensive evaluation concludes in a road map incl. your actions.
You get deliverables
- Evaluation report
- Gap analysis
- Action list
- Road map
After the evaluation you get an offer for a certification. Right after signing partnering the certification process starts.
You obtain your product’s CE mark by passing development and production phase. We review development phase deliverables, support in different fields like the risk management, write compilation and oversee completion of the technical documentation to standards. Then, we handle the certification procedure with our Notified Body.
You get CE mark
- Regulatory guidance
- Overtaking regulatory responsibility
- Compliant tech file
- Assessments & audits
- Preparations for further markets
To stay in the market, Decomplix maintains your product’s certification and stands at your side for quality and regulatory tasks.
By going to the market with your first product, Decomplix takes over the regulatory responsibilities for end-users and authorities in the maintenance phase. The partnership is detailed in a collaboration and quality assurance agreement over a three years maintenance period. This comprehensive evaluation concludes in a roadmap incl. Your actions.
You keep your CE mark
- Post market surveillance
- Complaint handling
- Incidents reporting / FSCA
- Periodic reportings